Clinical Trial: Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

Brief Summary:

Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients.

However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse.

Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.

Detailed Summary:

Aims of the study were :

• to assess the overall efficacy of rituximab in a cohort of unselected patients with hairy-cell leukemia
• to identify factors associated to treatment response, to duration of treatment response and to patient survival in a cohort of unselected patients with hairy-cell leukemia

Sponsor: CHU de Reims

Current Primary Outcome: Complete hematologic response to rituximab therapy [ Time Frame: Month 6 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: CHU de Reims

Dates:
Date Received: August 25, 2016
Date Started: June 2012
Date Completion:
Last Updated: August 25, 2016
Last Verified: August 2016